SCIPRO Flexible Stone Dislodger and Retrieval Set Catalog # SP3000146ST
FDA device recall Z-0554-04 · posted 2004-02-27 · Terminated
Recall details
- Recalling firm
- Scion Cardio-Vascular, Inc.
- Reason for recall
- Possible difficulty for the user in opening the stone retrieval basket.
- Action taken
- The firm mailed a recall letter on May 23, 2003 with a pre-paid FedEx shipment label to the consignees requesting that they return the indicated product and lot number. The firm recieved a response from each consignee and accounted for all shipped product by 6/24/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGO
- Quantity affected
- 28
- Distribution
- Product was distributed 12 hospitals and clinics in NJ, RI, NY, PA, VA, KY, TX, OH, TX AND FL.
- Date initiated
- 2003-05-23
- Date posted
- 2004-02-27
- Date terminated
- 2004-05-07
- Location
- Miami, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET (K001563) | Scion Cardiovascular, Inc. | 2000-11-22 |